(144 days)
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No
The summary describes a fluorescence qualitative nucleic acid hybridization assay, which is a laboratory technique and does not mention any AI or ML components.
No
The device is a diagnostic assay for identifying Candida albicans, aiding in diagnosis rather than providing therapy.
Yes
Because the "Intended Use / Indications for Use" section explicitly states, "C. albicans PNA FISH is indicated for use as an aid in the diagnosis of C. albicans fungemia."
No
The device is a fluorescence qualitative nucleic acid hybridization assay, which is a laboratory test involving physical reagents and processes, not solely software.
Based on the provided information, the device described, "C. albicans PNA FISH," is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "fluorescence qualitative nucleic acid hybridization assay intended for identification of Candida albicans on smears made from yeast positive blood cultures." This involves testing biological samples (blood cultures) outside of the body to provide information for diagnosis.
- Aid in Diagnosis: The indication for use states it is "indicated for use as an aid in the diagnosis of C. albicans fungemia." This directly links the device's function to providing diagnostic information.
These points clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
C. albicans PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of Candida albicans on smears made from yeast positive blood cultures.
Subculturing of yeast positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
C. albicans PNA FISH is indicated for use as an aid in the diagnosis of C. albicans fungemia.
Product codes
NZS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol of a human figure, represented by three overlapping profiles facing to the right, suggesting a sense of community and support.
10903 New Hampshire Avenue Silver Spring, MD 20993
Advan Dx, Inc. C/o Paula Bulger Director of Regulatory Affairs 400 Trade Center, Suite 6990 Woburn, MA 01801-7476
MAR 13 2012
Re: K092655
Trade/Device Name: C. albicans PNA FISH™ Regulation Number: 21 § CFR 866.2660 Regulation Name: Candida albicans Culture Identification Kit Regulatory Class: Class I Product Code: NZS Dated: January 11, 2010 Received: January 12, 2010
Dear Ms. Bulger:
This letter corrects our substantially equivalent letter of January 19, 2010.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good
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Page 2 - Paula Bulger
device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sai asayto
Sally A.Hojvat, M.Sc., Ph.D Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: C. albicans PNA FISH®
Indications for Use:
C. albicans PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of Candida albicans on smears made from yeast positive blood cultures.
Subculturing of yeast positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
C. albicans PNA FISH is indicated for use as an aid in the diagnosis of C. albicans fungemia.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR:801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
:(k) K092655